FOOD GRADE QUALITY OF PLASTICS AND REGULATIONS 47

Chapter
3
FOOD GRADE QUALITY
OF PLASTICS AND
REGULATIONS

Baldev Raj

Food Packaging Technology Department

Central Food Technological Research Institute
Mysore 570 020 (INDIA)

PLASTICS IN FOOD PACKAGING

48 Chapter 3

PLASTICS IN FOOD PACKAGING

FOOD GRADE QUALITY OF PLASTICS AND REGULATIONS
FOOD GRADE QUALITY OF
PLASTICS AND REGULATIONS
ROLE OF ADDITIVES IN
PLASTICS
In addition to the basic polymers, plastics
also contain additional chemical compo-
nents called additives, which are added in
small amounts to alter the properties of the
polymers in the desired way and/or simplify
their processing. Only fillers and softeners
(plasticizers) are used at high concentration
to increase volume and/or weight to improve
softening, flexibility, elasticity, malleability
and processability. Other additives are
mostly low molecular weight components
like stabilizers, anti-oxidants, antistatic
agents, light stabilizers (UV absorbers),
lubricants (slip agents), optical brighteners,
etc. Polymer packaging materials may also
contain small quantities of monomers,
oligomers as well as polymerization catalysts
and regulators, cross-linking agents,
emulsifer agents, etc. These additives along
with low molecular weight non-polymeric
components, which occur from plastic
packaging materials, possess high mobility.
It is likely that some transfer of low-molecular
weight non-polymeric components will
occur from the plastic packaging material
into the packaged content, thereby
contaminating the product with the risk of
PLASTICS IN FOOD PACKAGING
49
Chapter 3
toxic hazard to the consumer. However, it is
to be remembered that useful properties of
the plastics are not manifested without the
addition of these additives. Therefore,
guidelines for proper use of plastics for food
packaging applications have been
formulated all over the world, which are
necessary to safeguard health of the
consumer.
Concern over the safety-in-use of plastics
as food packaging materials arises
principally from the possible toxicity of other
low molecular weight constituents that may
be present in the package and hence, get
leached into the foodstuff during storage. As
stated above, such constituents arise from
two sources:
Polymerisation residues including
monomers, oligomers (with a molecular
weight up to about 200), catalysts (mainly
metallic salts and organic peroxides),
solvents, emulsifiers and wetting agents, raw
material impurities, plant contaminants,
inhibitors, decomposition and side reaction
products.
The more volatile gaseous monomers,
such as ethylene, propylene and vinyl
chloride, usually fall in concentration with
50
time, but very low levels may persist in the
finished product almost indefinitely. Styrene
and acrylonitrile residues are more difficult
to remove.
Processing aids such as antioxidants,
antiblock agents, antistatic agents, heat and
light stabilizers, plasticisers, lubricants and
slip agents, pigments, fillers, mould release
agents and fungicides are added to assist
production processes or to enhance the
properties and stability of the final product.
They may be present in amounts varying
from only a few parts per million up to
several parts per cent.
Since compounds of the first group are
present inadvertently, there is not much that
can be done to remove them. However, the
efforts made by the industry to reduce vinyl
chloride monomer levels in particular,
illustrates the advantages of optimum
manufacturing processes on the purity of
the final product. Chemicals added delibe-
rately during formulation to alter the
processing, mechanical or other properties
of the polymer are likely to be present in
greater amounts than polymerization
residues and should be subjected to strict
quality control. They are normally restricted
to compounds appearing on an approved
list for food contact use. A brief account of
the functions of some major additives is
presented below:
Antiblock Agents
These are added to roughen the surface
of thin films and, hence, prevent them
sticking together during machine processing.
Silica is most commonly used because its
poor solubility in most polymers helps to
increase the surface concentration and so
introduces irregularity. Similarly, slip
additives such as fatty acids and amides are
used to reduce mobility.
Chapter 3
Antioxidants
These prevent degradation of the polymer
by reacting with atmospheric oxygen during
moulding operations at high temperatures
or when used in contact with hot foods and
to prevent deterioration during storage. Deri-
vatives of phenols and organic sulphides
are the most frequently used antioxidants.
Some of these compounds are classified as
heat stabilizers.
Antistatic Agents
Since all plastics are good electrical
insulators (and are in fact used on a large
scale for this purpose) they will retain
electrostatic charges produced by friction
from contact with processing machinery.
Accumulation of static electricity can cause
problems through the pick-up of dust,
adhesion between layers or particles of
plastics, sparking, electrical shock and
possibly fire hazards. Most antistatic agents
are glycol derivatives or quaternary ammo-
nium compounds; both increase the electrical
conductivity and plate-out onto the surface
of plastic.
Lubricants
These are added to reduce frictional
forces and are usually low to medium
molecular weight hydrocarbons. They
should possess good solubility with the
plastic, low volatility and be relatively stable
compounds.
Plasticizers
These are added to make the product
more flexible and less brittle. They are usually
high molecular weight esters. The plasticizer
also gives the material the limp and tacky
qualities found in “cling” films. About 80%
of all plasticizers are used in PVC. Typically
PLASTICS IN FOOD PACKAGING
FOOD GRADE QUALITY OF PLASTICS AND REGULATIONS
phthalic esters such as dioctyl phthalate
(DOP), also known as di-2-ethylhexyladipate
(DEHA) are used as plasticizers.
UV Stabilizers
These are needed to protect the product
from deterioration by sunlight or even
supermarket lighting. Products containing
vitamin C are particularly susceptible to this
form of deterioration.
Optical Property Modifiers
The optical properties of a material from
a technological aspect are normally described
in terms of their ability to transmit light, to
exhibit colour and reflect light from the
surface (i.e, gloss). The majority of food
packaging films are unpigmented, but some
are coloured by the addition of colorants.
The principal pigments used as colourants
in packaging are carbon black, white
titanium dioxide, red iron oxide, yellow
cadmium sulfide, molybdate orange,
ultramarine blue, blue ferric ammonium ferric
ammonium, ferrocyanide, chrome green, and
blue and green copper phthalocyanines.
Fire Retardants
Although most packaging materials are
combustible, their lack of flame resistance is
disregarded in most food packaging
applications. For example, thermoformed
polystyrene cups and plates are combus-
tible; the risk of fire must be balanced against
the possible toxicity of flame retardant
additives.
Foaming Agents
Foaming or blowing agents are used for
the production of cellular products and are
normally classified into physical and
chemical types, according to whether the
generation of gases to produce the cells takes
PLASTICS IN FOOD PACKAGING
51
place through a physical transition i.e.
evaporation or sublimation or by a chemical
process i.e. decomposition reactions which
result in evolution of gases. In food packaging
applications, physical blowing agents are
normally used. For example, expanded and
extruded polystyrene foams use a fluoro-
carbon or light aliphatic hydrocarbon such
as pentane as the blowing agent.
Antimicrobial Agents
Antimicrobials such as algicides,
bactericides and fungicides can be added to
polymers to prevent the growth of micro-
organisms. However, their use in food
packaging is rare because of the possibility
of migration into the food itself.
MIGRATION OF ADDITIVES
The ingredients in the plastics packaging
materials may cause toxicity as a result of
their migration to the foodstuffs in which the
latter are packed. Therefore, positive lists of
constituents (additives) to be used in
respective plastics in contact with foodstuffs,
pharmaceuticals and drinking water have
been specified. The manufacturer has to
follow a Good Manufacturing Practice
(GMP) using only those additives listed in
the positive list. Prior to categorizing any
plastics as toxic, evidence regarding degree
of migration of their constituents has to be
ascertained. In general, migration and
extraction studies need to be simultaneously
conducted on actual foodstuffs under
conditions, which are slightly more stringent
than those encountered in normal usage. It
is, however, not always possible to analyse
actual foodstuffs for the nature and quantity
of migrants from the plastics. In order to
simplify such assessment, food simulants/
extractants have to be substituted for the
actual foodstuffs. Further, it is also very
52
difficult to estimate all the migrants
individually. Hence, as a good measure, the
overall migration of all the migrants put
together is considered for safe use, unless
they are especially toxic and their limits are
fixed.
Migration Model
The extent of migration of a substance
depends on its concentration in the material,
the extent to which it is bound or mobile
within the matrix of the material, the thickness
of the packaging material, the nature of the
food with which the material is in contact
(dry, aqueous, fatty, acidic, alcoholic), the
solubility of the substance in the food, the
duration of contact and temperature.
In a system of polymer/food as presented
in the figure below, we have the food on the
left which can migrate into the polymer layers
on the right side, along with an intermediate
layer of swollen polymer with a profile of the
migrating food component. On the other
hand, we have a concentration gradient of
the considered additives, where we assume
that we have a certain diffusion in the
undisturbed polymer layer and a much
improved mobility of the additive in the
swollen layer and concentration jump at the
interfaces.
Rudolph particularly considered the
consequence of the model. The following
general formula relates the migration of an
additive. In a system where a cut of the
plastic P into a food F at a certain time t, is
kept at constant temperature, the model
predicts direct proportionality of migration
of the concentration CPA of the considered
additive in the polymer and to the square
root of time (t).
MFA (T) = α CPA √t
Chapter 3
MFA (T) is concentration of migrating
T and α is is a proportionality constant.
additive A into test food F, at a temperature
where, CAF is concentration of additives
in food
CFP is concentration of food in
polymer
CAP+F is concentration of additive in
polymer and food, which has
penetrated into polymer.
CAP is concentration of additive in
polymer
INDIAN STANDARDS FOR
OVERALL MIGRATION
(IS: 9845-1998)
CFTRI drafted IS:9845-1998 for “Determi-
nation of overall migration of constituents of
plastics materials and articles intended to
come in contact with foodstuffs - method of
analysis (second-revision)” which is now
implemented to be followed for overall
migration of plastics constituents for their
food grade quality in the country. This
standard is the result of R & D work on the
study of various factors affecting the
migration of additives in food simulants, in
the laboratory and is at par with other
International standards like US-FDA, ECC
Directives, etc. A collection of data regarding
the main composition and overall extractable
amount of plastic constituents can help with
PLASTICS IN FOOD PACKAGING
FOOD GRADE QUALITY OF PLASTICS AND REGULATIONS 53

Table 3.1. Classification of foods and selection of simulants

Type Description Examples Simulants
I Aqueous, non acidic Honey, mineral water, sugar ‘A’ (Water)
foods (pH>5) without syrups, molasses, skimmed
fat. milk, rasgulla, murabba, paste
etc.
II Aqueous, acidic foods Fruit juices, squashes, fruit chunks ‘B’
(pH<5) without fat or puree or paste, vinegar, jams, (3% Acetic
jellies, carbonated beverages, acid)
lemonde, processed vegetables,
preparation of soups, broths,
sauces, RTS beverages, etc.
III Alcoholic beverages: ‘C1’
i) Alcohol concentra- Beer and some pharmaceutical (10% Ethanol)
tion less than 10%. syrups. ‘C2’
ii) Alcohol concentra- Wine, brandy, whiskey, arrack (50% Ethanol)
tion above 10% and other alcoholic drinks.
IV Oils, fats and processed Vegetable oils, ghee, vanaspati ‘D’
dry foods with surface cocoa butter, lard, dry products (n-Heptane)
fat or volatile oils with a surface fat such as biscuits,
spice powder, snacks and savory,
chocolate, caramels, malted foods
egg powder, tea coffee powder,
confectionery, fried and roasted
nuts, etc.
V Non-acidic foods Butter, bread, pastry, cakes, milk- ‘A and D’
(pH>5) or high fat and based sweets, ice-cream, moist and
having high moisture fatty confectionery products.
content
VI Acidic foods (pH<5) Pickles, ketchup, cheese, curd, ‘B and D’
or high fat and having fresh and processed meat and
high moisture content fish products, sauces having fat,
frozen foods, etc.
VII. Dry processed foods Cereals and pulses, dehydrated Only ‘A’
without fat vegetable and fruits, dried yeast,
corn flakes, salt, sugar, milled
products, barley powder, oats,
vermicelli, grain, etc.

PLASTICS IN FOOD PACKAGING

54
the estimation of migration. This can be a
considerable asset to both the producers of
such articles and for quality control labo-
ratories. Much time and money may also be
saved if studies are made on the evaluation
of laminates containing layers of recycling
material with unknown impurities which
can migrate through the virgin plastic layer
(functional barrier) in contact with food.
The choice of simulating solvents and
test conditions (time-temperature) depends
on the type of foods and conditions of use of
food products. Food products have been
now classified into seven major groups as
shown in Table 3.1. This table has been pre-
pared on the lines of accepted classification
of foodstuffs for such purpose. The table also
gives suitable simulants to be used for
different types of foods.
Table 3.2 lists the simulants and test
conditions (time-temperature) for extracta-
bility studies to be carried out depending on
the type of food and conditions of use.
Selection of Samples
Minimum triplicate samples represen-
ting the lot/batch have to be selected.
Samples in each replicate shall consist of a
number of containers (preformed or
converted products) with nearest exposed
area of 1,000 cm2. In the case of sealable films
representative sample shall be of sufficient
size to convert into 2 pouches of size 125 mm
width and 200 mm length (inner dimension
excluding seal area) and non-heat sealable
films of size 50 cm × 10 cm to be exposed over
both the sides with 1,000 cm2 surface area
coming in contact. In case of lids/wads, ten
pieces are to be sealed to glass bottles of
smallest size, in actual use to be placed
inverted in position during the test period.
Chapter 3
Preparation of Test Specimen
The containers/pouches/film/lids used
shall be carefully rinsed with water (25-
30°C) to remove extraneous materials prior
to actual migration test.
Simulant Quantity
Equal to nominal filling capacity or at
least 1 ml/cm2 of contact area.
Procedure
Fill the container/pouch to their filled
capacity or non-heat sealable film to be
exposed both sides with preheated simulant
at test temperature and close it. In case of
pouches, exclude air as much as possible
before sealing and expose the filled
container/pouch to specified temperature
maintained in oven/water bath/autoclave
for the specified duration. Remove the
container/pouch and transfer the contents
immediately into a clean Pyrex beaker along
with three washings of the specimen with
small quantity of the fresh simulant.
Determination of Amount of
Extractive
Evaporate/distill the contents in Pyrex
beaker/round bottom flask to about 50-60
ml and transfer into a clean tared stainless
steel dish along with 3 washings with small
quantity of fresh simulant and further
evaporate the concentrate in the dish to
dryness in an oven at 100±5°C. Cool the
dish with extractives in a desiccator for 30
minutes and weigh to nearest 0.1 mg till
constant weight of residue is obtained.
Calculate the extractives in mg/dm 2
and mg/kg or ml/l or ppm of the foodstuff
with respect to the capacity of container/
pouch to be used. Blank shall also be carried
out without the sample for adjustment, if
necessary.
PLASTICS IN FOOD PACKAGING
FOOD GRADE QUALITY OF PLASTICS AND REGULATIONS 55

Table 3.2. Simulating solvents for different types of foods and

temperature-time conditions
Type Migration Test Wiw Food simulants-
Conditions of use of Temperature, Time Conditions (°C)
Food
Water 3% 10% 50% n-Heptane*
acetic alcohol alcohol
acid
(A) (B) (C1) (C2) (D)

High temperature I, II, 121°C/2h - - 66°C/2h

heat sterilized IV, V
(Retorting) & VI

Hot filled or I, II 100°C/2h - - 49°C/0.5h

pasteurized IV, V
above 66°C, & VI
below 100°C

Hot filled or I to 70°C/2h 38°C/0.5h

pasteurized IV
below 66°C

Room tempera- I to 40°C/10 dyas 38°C/0.5h

ture filled and IV
stored and also
in refrigerated
and frozen
condition (no
thermal treatment
in container)

Heptane extractivity results must be divided by a factor of five in arriving at the extractivity of a food
product.

of simulants, the limit shall be 60 mg/l or

Migration Limits
The material shall comply with the overall
migration limit when tested by the method
prescribed in IS: 9845-1998, mg/kg, Max, of
foodstuff. In the case of liquid foodstuffs or
ppm., Max. However, the value of the overall
migration limit shall be equal to 10 mg/dm2,
Max, of the surface of the material or article.
In case of lids/wads the results can be
expressed only as mg/kg, 60 mg/l or ppm.

PLASTICS IN FOOD PACKAGING

56 Chapter 3

M
Amount of extractive (Ex) = × 100 mg/dm2,
A
M
× 1000 mg/kg or mg/l and/or ppm
V
where,
M = mass of residue in mg minus blank value
A = total surface area in cm2 exposed in each replicate, and
V = total volume in ml of simulant used in each replicate

Indian Standards for plastics suitable for use in contact with food-
stuffs, pharmaceuticals and drinking water are listed below:
IS No. Title
10171:1999 Guide on suitability of plastics for food packaging (second-
revision).
9833:1981 List of pigments and colorants for use in plastics in contact with
foodstuffs, pharmaceuticals and drinking water.
9845:1998 Determination of overall migration of constituents of plastics
materials and articles intended to come in contact with food-
stuffs — method of analysis (second-revision).
10141:1982 Positive list of constituents of polyethylene in contact with
foodstuffs, pharmaceuticals and drinking water (first-revision).
10142:1999 Polystyrene (crystal and high impact) for its safe use in contact
with foodstuffs, pharmaceuticals and drinking water (first-
revision).
10146: 1982 Polyethylene for its safe use in contact with foodstuffs,
pharmaceuticals and drinking water.
10148:1982 Positive list of constituents of polyvinyl chloride and its
copolymers for safe use in contact with foodstuffs,
pharmaceuticals and drinking water.
10149:1982 Positive list of constituents of polystyrene (crystal and high
impact) in contact with foodstuffs, pharmaceuticals and
drinking water.
(continued on next page)

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FOOD GRADE QUALITY OF PLASTICS AND REGULATIONS 57

(continued from previous page)

10151:1982 Polyvinyl Chloride (PVC) and its copolymers for their safe use
in contact with foodstuffs, pharmaceuticals and drinking water.
10909:1984 Positive list of constituents of polypropylene and their
copolymers for their safe use in contact with foodstuffs,
pharmaceuticals and drinking water (first-revision).
10910:1984 Polypropylene and its copolymers for their safe use in contact
with foodstuffs, pharmaceuticals and drinking water.
11434:1985 Ionomer resins for their safe use in contact with foodstuffs,
pharmaceuticals and drinking water.
11435:1985 Positive list of constituents of ionomer resins for their safe use
in contact with foodstuffs, pharmaceuticals and drinking water.
11704:1986 Ethylene/acrylic acid (EAA) copolymers for their safe use in
contact with foodstuffs, pharmaceuticals and drinking water.
11705:1986 Positive list of constituents of Ethylene/acrylic acid (EAA)
copolymers for their safe use in contact with foodstuffs,
pharmaceuticals and drinking water.
12229:1987 Positive list of constituents of polyalkylene terephthalates (PET
& PBT) for their safe use in contact with foodstuffs,
pharmaceuticals and drinking water.
12247:1998 Nylon-6 polymer for its safe use in contact with foodstuffs,
pharmaceuticals and drinking water.
12248:1998 Positive list of constituents of Nylon-6 polymer for their safe use
in contact with foodstuffs, pharmaceuticals and drinking water.
12252:1987 Polyalkylene terephthalates (PET & PBT) for their safe use in
contact with foodstuffs, pharmaceuticals and drinking water.
13449:1992 Positive list of constituents of ethylene vinyl acetate (EVA) for
their safe use in contact with food stuffs, pharmaceuticals and
drinking water.
13576:1992 Ethylene methacrylic and (EMMA) copolymer and terepolymers
for their safe use in contact with foodstuffs, pharmaceuticals
and drinking water.
13557:1992 Positive list of constituents of ethylene methacrylic (EMMA)
copolymer and terepolymers in contact with foodstuffs,
pharmaceuticals and drinking water.
(continued on next page)

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58 Chapter 3

(continued from previous page)

13601:1993 Ethylene vinyl acetate (EVA) copolymers for their safe use in
contact with foodstuffs, pharmaceuticals and drinking water.
Doc: PCD 12(1328) Positive list of constituents of polycarbonate resins in contact
with foodstuffs, pharmaceuticals and drinking water.
Doc: PCD12 (1329) Polycarbonate resins for their safe use in contact with foodstuffs,
pharmaceuticals and drinking water.
Doc: PCD 12(1331) Positive list of constituents of Melamine-Formaldehyde resins
in moulded articles in contact with food stuffs, pharmaceuticals
and drinking water.
Doc: PCD 12(1332) Melamine-Formaldehyde resins in moulded articles in contact
with foodstuffs, pharmaceuticals and drinking water.
Doc: PCD 12(1375) Positive list of constituents of Modified Poly (Phenylene Oxide)
(PPO) in contact with food stuffs, pharmaceuticals and drinking
water.
Doc: PCD 12(1375) Modified Poly (Phenylene Oxide) (PPO) resins in contact with
foodstuffs, pharmaceuticals and drinking water.
Doc: PCD 12(1516) Positive list of constituents of unsaturated polyester resins in
contact with foodstuffs, pharmaceuticals and drinking water.

FOOD AND DRUGS results from use of the substance in an

ADMINISTRATION, UNITED
STATES
In the United States of America all the
packaging materials are evaluated for food
contact application as per the Code of Federal
Regulations 21, Parts 170 to 199, Revised
as of April1, 2001 Food and Drugs. (Table
3.3 and 3.4).
Indirect Food Additives: General
Regulations prescribe that food additive
substances may be safely used under
conditions of good manufacturing practice.
The quantity of any food additive substance
that may be added to food as a result of use
in articles that contact food shall not exceed,
where no limits are specified, that which
amount not more than reasonably required
to accomplish the intended physical or
technical effect in the food-contact article;
shall not exceed any prescribed limitations;
and shall not be intended to accomplish any
physical or technical effect in the food itself,
except as such may be permitted by the
regulations.
Any substance used as a component of
articles that contact food shall be of purity
suitable for its intended use.
The existence of a regulation prescribing
safe conditions for the use of substance as an
article or component of articles that contact
food shall not be construed as implying that
such substance as an article or component
or articles that contact food shall not be

PLASTICS IN FOOD PACKAGING

FOOD GRADE QUALITY OF PLASTICS AND REGULATIONS 59

Table 3.3. Types of raw and processed foods (US FDA)

I. Nonacid (pH above 5.0), aqueous products; may contain salt or sugar or both.
II. Acid (pH 5.0 or below), aqueous products; may contain salt or sugar or both,
and including oil-in-water emulsions of low- or high-fat content.
III. Aqueous, acid or nonacid products containing free oil or fat; may contain salt
and including water-in-oil emulsions of low- or high-fat content.
IV. Dairy Products and modifications A. Water-in-oil emulsions, high - or low -
fat B. Oil-in-water emulsions, high - or low -fat.
V. Low-moisture fats and oil.
VI. Beverages: A. Containing up to 8% alcohol. B. Non alcoholic C. Containing
more than 8% alcohol.
VII. Bakery products other than those included under types 8th or 9th of this table.
a) Moist bakery products with surface containing free fat or oil.
b) Moist bakery products with surface containing no free fat or oil.
VIII. Dry solids with the surface containing no free fat or oil (no end-test required).
IX. Dry solids with the surface containing free fat or oil.
construed as implying that such substance (e.g., food-packaging or food-processing
may be safely used as a direct additive in equipment) that migrate, or that may be
food. Substances that under conditions of expected to migrate, into food at negligible
good manufacturing practice may be safely levels may be reviewed under the regulation.
used as components of articles that contact The Food and Drug Administration will
food include the following subjects to any exempt substances whose uses it determines
prescribed limitations: meet the criteria.
v Substances generally recognized as safe Migration Limits
in or on food
In the finished form in which it is to
v Substances generally recognized as safe contact food, when extracted with the solvent
for their intended use in food packaging or solvents characterizing the type of food,
v Substances used in accordance with a and under conditions of time and tempe-
rature characterizing the conditions or its
prior sanction or approval
intended use as determined from Tables 3.3
Threshold of the Regulation and 3.4, the extractives shall not exceed 0.5
milligram per square inch of food-contact
for Substances Used in
surface nor exceed 50 parts per million of the
Food-contact Articles water capacity of the container in general or
Substances used in food-contact articles otherwise limits specified for specific

PLASTICS IN FOOD PACKAGING

60 Chapter 3

Table 3.4. Test procedures with time-temperature conditions for

determining amount of extractives from the food contact surface or
uncoated or coated paper and paper-board, using solvents simulating
types of foods and beverages (USFDA)
Type Extractant
Conditions of
of use
Code

Food Water, n-Heptane, 8% 50%

time time alcohol, alcohol,
and and time & time &
temp. temp. temp. temp.
A High temperature I, IV B, VII B 250°F, - - -
heat sterilized III, IV-A, 2h 150°F, 2h - -
(eg., over 212°F) VII A -do-
B Boiling water I, VII B 212°F, - - -
sterilized 30 min
III, VII A -do- 120°F, 30 min - -
C Hot filled or II, IV B, Fill - - -
pasteurized VII B boiling
above 150°F Cool to
100°F

III, IV A - 120°F, 15 - -
VII A
V, IX - -do- - -

D Hot filled or II, IV B, VI B - - - -

pasteurized VII B 150°F, 2h - - -
below 150°F III, IV A, - 100°F, 30 min - -
VII A
V, IX - -do- 150°F, 2h -
VI A - - - -
VI C - - - 150°F, 2h

E Room temperature I, II, IV B, 120°F, - - -

filled & stored (no VI B, VII B 24hr
thermal rated & III, IV A, -do- 70°F, 30 min - -
frozen treatment VII A
in container) & V, IX - - 120°F, 24 h -
also in refrige- VI A - - - 120°F,
rated & frozen VI C 24hr
condition
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(continued from previous page)

F Refrigerated III, IV A, 70°F, 70°F, - -

storage VII A 48 hr 30 min
(no thermal I, II, IV B, -do- - - -
treatment in the VII B
container) VI A - - 70°F, 48 h -
VI C - - - 70°F, 48 h
G Frozen storage I, II, IV B 70°F, - - -
(no thermal VII B 24 hr
treatment in the III, VII B -do- 70°F, - -
container) 30 min

material when tested as per the prescribed EEC DIRECTIVES ON PLASTIC

method.
Further, most of the indirect food addi-
tives used as adjuvant, production aids
and sanitizers for the manufacture of
polymers coming in contact with food
stuffs are covered under part 178 of Code
of Federal Regulations 21 (Food and
Drugs). Similarly, irradiation in the
production, processing and handling of
food and packaging materials for irradiated
foods have been covered under part 179 of
the US-FDA regulation.
CONTAINERS FOR FOODS
At the European level, Framework
Directive 89/109/ECC defines comparable
general requirement for Plastic Container. In
the early 1980’s, corresponding separate
directives in the field of plastic utensils were
adopted at the European level, which also
included procedures for carrying out such
migration tests. European regulations have
been harmonized to a large extent at least
with regard to admissible monomers and
starting substances (positive lists) as well as

The various specifications of US-FDA for plastic polymers coming in

contact with foodstuffs are listed below (Indirect food additives):
Substances for Use Only as Components of Adhesives:
175.105 Adhesives.
175.125 Pressure-sensitive adhesives.
Substances for Use as Components of Coatings:
175.210 Acrylate ester copolymer coating.
175.230 Hot-melt strippable food coatings.
175.250 Paraffin (synthetic).
175.260 Partial phosphoric acid esters of polyester resins.
175.270 Poly (vinyl fluoride) resins.
175.300 Resinous and polymeric coatings. (continued on next page)

PLASTICS IN FOOD PACKAGING

62 Chapter 3

(continued from previous page)

175.320 Resinous and polymeric coatings for polyolefin films.
175.350 Vinyl acetate/crotonic acid copolymer.
175.360 Vinylidene chloride copolymer coatings for nylon film.
175.365 Vinylidene chloride copolymer coatings for polycarbonate film.
175.380 Xylene-formaldehyde resins condensed with 4,4’-isopropylidene-
diphenol - epichlorohydrin epoxy resins.
175.390 Zinc-silicon dioxide matrix coatings.
Substances for Use Only as Components of Paper and Paperboard:
176.170 Components of paper and paperboard in contact with aqueous and fatty
foods.
176.180 Components of paper and paperboard in contact with dry food.
Polymers : Substance for use as basic components of single and
repeated use food contact surfaces:
177.1010 Acrylic and modified acrylic plastics, semirigid and rigid.
177.1020 Acrylonitrile/butadiene/styrene copolymer.
177.1030 Acrylonitrile/ butadiene/styrene methyl methacrylate copolymer.
177.1040 Acrylonitrile/ styrene copolymer.
177.1050 Acrylonitrile/ styrene copolymer modified with butadiene/styrene elas-
tomer.
177.1060 n-Alkylglutarimide/acrylic copolymer.
177.1200 Cellophane.
177.1210 Closures with sealing gaskets for food containers.
177.1211 Cross-linked polyacrylate copolymers.
177.1240 1,4-Cyclohexylene dimethylene terephthalate and 1,4-cyclohexylene
dimethylene isopthalate copolymer.
177.1310 Ethylene-acrylic acid copolymers.
177.1312 Ethylene-carbon monoxide copolymers.
177.1315 Ethylene-1, 4-cyclohexylene dimethylene terephthalate copolymers.
177.1320 Ethylene-ethyl acrylate copolymers.
177.1330 Ionomeric resins.
177.1340 Ethylene-methyl acrylate copolymers resins.
177.1345 Ethylene/1, 3-phenyle oxygenthelene isophthalate/terephthalate co-
polymer.
(continued on next page)

PLASTICS IN FOOD PACKAGING

FOOD GRADE QUALITY OF PLASTICS AND REGULATIONS 63

(continued from previous page)

177.1350 Ethylene-vinly acetate copolymers.
177.1360 Ethylene-vinly acetate-vinly alcohol copolymers.
177.1380 Fluorocarbon resins.
177.1390 Laminate structures for use at temperatures of 250°F and above.
177.1400 Hydroxyethyl cellulose film, water insoluble.
177.1420 Isobutylene polymers.
177.1430 Isobutylene-butene polymers.
177.1440 4, 4-isopropylidene diphenol-epichlorohydrin resins, minimum mole-
cular weight 10,000.
177.1460 Melamine-formaldehyde resins in molded articles.
177.1480 Nitrile rubber modified acrylonitrile-methyl acrylate copolymer.
177.1500 Nylon resins.
177.1520 Olefin polymers.
177.1550 Perfluorocarbon resins.
177.1555 Polyarylate resins.
177.1556 Polyaryletherketone resins.
177.1560 Polyarylsulfone resins.
177.1570 Poly 1-butene resins and butene/ethylene copolymers.
177.1580 Polycarbonate resins.
177.1585 Polyester carbonate resins.
177.1590 Polyester elastomers.
177.1595 Polyetherimide resin.
177.1600 Polyethylene resins, carboxyl modified.
177.1610 Polyethylene, chlorinated.
177.1615 Polyethylene, fluorinated.
177.1650 Polyethylene, oxidized.
177.1630 Polyethylene phthalate polymers.
177.1632 Poly (phenylene terephthalamide) resins.
177.1635 Poly (p-methylstyrene) and rubber modified poly (p-methylstyrene).
177.1637 Poly (oxy-1, 2 ethanediyloxycarbonyl-2, 6-naphthalenediyl) resins.
177.1640 Polystyrene and rubber-modified polystyrene.
(continued on next page)

PLASTICS IN FOOD PACKAGING

64 Chapter 3

(continued from previous page)

177.1650 Polysulfide polymer-polyepoxy resins.
177.1655 Polysulfone resins.
17731670 Poly (teramethylene terphthalate).
177.1670 Polyvinly alcohol film.
177.1680 Polyurethane resins.
177.1810 Styrene block polymers.
177.1820 Styrene-maleic anhydride copolymers.
177.1830 Styrene-methyl methacrylate copolymers.
177.1850 Textryls.
177.1900 Urea formaldehyde resins in molded articles.
177.1950 Vinyl chloride-ethylene copolymers.
177.1960 Vinyl cloride-hexane-1 copolymers.
177.1970 Vinyl chloride-lauryl vinyl ether copolymers.
177.1980 Vinyl chloride-propylene copolymers.
177.1990 Vinylidene chloride-methyl acrylate copolymer.
177.2000 Vinylidene chloride/methyl acrylate/methyl methacrylate polymers.
Substance for use only as components of articles intended for repeated use:
177.2210 Ethylene polymer, chlorosulfonated.
177.2250 Filters, microprous polymeric.
177.2260 Filters, resin-bonded.
177.2280 4, 4’ - Isopropylidenediphenol epichlorohydrin thermosetting epoxy
resins.
177.2355 Mineral reinforced nylon resins.
177.2400 Perflurocarbon cured elastomers.
177.2410 Phenolic resins in molded articles.
177.2415 Poly (aryletherketone) resins.
177.2420 Polyesterylate/poly (trimethoxysilylpropy) methacrlate co-polymers.
177.2430 Polyester resins, chlorinated.
177.2440 Polyestersulfone resins.
177.2450 Polyamide-imide resins.
(continued on next page)

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FOOD GRADE QUALITY OF PLASTICS AND REGULATIONS 65

(continued from previous page)

177.2460 Poly (2, 6-dimethyl-1, 4-phenylene) oxide resins.
177.2466 Polyoxymethacrylate/poly (trimethoxysilylpropy) methacrlate
co-polymers.
177.2470 Polyoxymethylene copolymer.
177.2480 Polyoxymethylene homopolymer.
177.2490 Polyphenylene sulfide resins.
177.2500 Polyphenylene sulfone resins.
177.2510 Polyvinylidene fluoride resins.
177.2550 Reverse osmosis membranes.
177.2600 Rubber articles intended for repeated use.
177.2710 Styrene-divinyl benzene resins, cross-linked.
177.2880 Textiles and textile fibers.
177.2910 Ultra-filtration membranes.

maximum admissible migration of ingre- admissible in principle. This examination is

dients of plastics utensils. This also applies
to overall migration limitations, maximum
admissible residual content of certain
monomers and starting substances in plastic
container [so-called QM(A) limits], maxi-
mum admissible migration limits of defined
specific substances [so-called SML(T)]. EC
Directives have laid down procedures for
selecting food simulants and also require-
ments for testing migration based on actual
conditions of use (time/temperature combi-
nations). On the other hand, the existing
European Directives mentioned above only
partly cover the use of plastic additives and,
at present, provide no regulations at all
with regard to aids to polymerisation and
colouring materials in plastics. In practice,
the evaluation of plastic container (in
particular packages) with regard to
compliance with food regulation is a two-
step procedure in most cases: at first, the
ingredients of the recipe are examined so as
to ensure that the materials used are
based on existing European Directive. If, in
this first step, all components of the recipe
turn out to be admissible in principle,
migration tests are carried out in the next
step in order to ensure that individual
components of the plastic container in
question (e. g., additives, colouring materials,
monomers, etc) are not transmitted to the
filling material (food stuff) to an inadmissibly
great extent. The corresponding tests are
preferably carried out directly on the
respective containers or on a test specimen
taken from it, with specific attention paid to
the requirement that the overall migration
limit and any specific migration limits be
met.
Migration Limits
In any such case, for substances exempt
from specific migration limits or other
restrictions in the list provided in Annex II,
a generic specific migration limit of 60 mg/
kg or 10 mg/dm2, according to the case, is

PLASTICS IN FOOD PACKAGING

66 Chapter 3

applied. However, the sum of all specific
migrations determined shall not exceed the
overall migration limit, when tested as per
Tables 3.5 and 3.6.
SPECIFIC MIGRATION OF
TOXIC ADDITIVES
In addition to creating safety and health
problems during production, many chemical
additives that give plastic products desirable
packaging qualities also have negative
environmental and human effects. These
effects include direct toxicity as in the case of
lead, cadmium and mercury. Most of the
colourful pots or kudams, which are locally
manufactured by recycling, would have
these toxic additives. Plastic containers can
contaminate food because some chemicals
diffuse from the packaging polymer of which
they are made to the foods they contain.
Migration potential exists for traces of
monomers, oligomers, additives, stabilizers,

Table 3.5. Simulants according to EU Directive 97/48/EC

Simulant A:
Distilled water for aqueous foods having a pH of 4.5 or more
Simulant B:
3% acetic acid (w/v) for aqueous foods and acidic foods having a pH < 4.5
Simulant C:
10% ethanol (v/v) for alcoholic foods
Simulant D:
Rectified olive oil for edible oils and fats as well as fatty foods in which fat
(is contained in a way that it) comes into direct contact
with the utensil in question.

Table 3.6. Migration tests of plastic materials and articles for certain
types of foods according to EU Directive 97/48/EC
Food type Simulant
Only aqueous foods A
Only acidic foods B
Only alcoholic foods C
Only fatty foods D
All aqueous and acidic foods B
All alcoholic and aqueous foods C
All alcoholic and acidic foods C and D
All fatty and aqueous foods D and A
All fatty and acidic foods D and B
All fatty, alcoholic and aqueous foods D and C
All fatty, alcoholic and acidic foods D, C and B

PLASTICS IN FOOD PACKAGING

FOOD GRADE QUALITY OF PLASTICS AND REGULATIONS 67

plasticizers and lubricants. Such substances
may be toxic. A report of the Berkeley (U.S.)
Plastics Task Force published in 1996 found
that styrene from polystyrene, plasticizers
from PVC, antioxidants from polyethylene
and acetaldehyde from PET have the
potential to contaminate food.
several countries. In recent years, however,
exposure to VCM at production and
polymerization plants has been markedly
reduced. It is well known that vinyl chloride
causes angiosarcomas of the liver as well as
tumours of the brain, lung and haemato-
lymphopoietic systems in humans.

Vinyl Chloride VCM limits : As per EEC directive, the

As per mutagenicity and metabolism of
VCM, a range of toxic effects has been reported
in human case studies. The principal effects
observed include lesions of the bones in the
terminal joints of the fingers and toes (acro-
osteolysis) as well as changes in the liver and
spleen. Long-term exposure gives rise to a
rare form of liver cancer (angiosarcoma) and
the association with exposure to VCM has
been reported amongst plant operatives in
level of vinyl chloride in materials and
articles and the level of vinyl chloride
released by materials and articles to
foodstuffs shall be 1 mg/kg of PVC material
and 0.01 mg/kg of food.
As per Indian standard, the vinyl chloride
monomer content of PVC suspension resin
used for the manufacture shall not exceed 5
ppm, and in the PVC containers/film used
for packaging shall not exceed 1 ppm. The

Table 3.7. European framework directives on separate materials

in contact with food are as follows:
Council Directive 89/109/ECC of 21 December 1988 (OJ L 040, 11/02/1989)
Directive 2002/72/ECC Plastic materials and articles.
Directive 90/128/ECC Plastic monomers.
Directive 82/711/ECC Basic rules for migration tests.
Directive 85/572/ECC List of simulants/foodstuffs.
Directive 80/766/ECC VC in PVC.
Directive 81/432/ECC Method of analysis for vinyl chloride released into
foodstuffs.
Directive 78/142/ECC Limits of vinyl chloride monomer.
Directive 80/590/ECC Determining symbols.
Directive 83/329/ECC Regenerated cellulose film (RCF).
Directive 84/500/ECC Ceramic articles.
Directive 86/388/ECC 1st amendment to 83/229/ECC.
Directive 92/15/ECC Amendment to 83/229/ECC.
Directive 93/8/ECC 1st amendment to 82/711/ECC.
Directive 93/11/ECC Nitrosamines in elastomers and rubber.
Directive 97/48/ECC 2nd amendment to 82/711/ECC.
Directive 2001/61/ECC Epoxy derivatives.

PLASTICS IN FOOD PACKAGING

68
residual migration of VCM into foodstuffs
being packed shall not exceed 10 ppb. The
method developed at CFTRI, Mysore, is
suitable for estimation of RVCM content in
PVC material and foods packed in them
upto 0.01 ppm levels.
Vinylidene Chloride
Less is known of toxicology of VDC, both
in animals and in humans. The LD value for
rats is around 1,500 mg/kg body weight,
while in mice the value is 200 mg/kg body
weight. VDC affects the activity of several rat
liver enzymes and decreases the store of
glutathione. Some tumours have been
observed after prolonged exposure but no
teratogenic effects were seen in rats or rabbits.
The main pathway of excretion is via the
lungs, with other metabolites being
discharged by the kidneys.
Acrylonitrile
AN is considerably more toxic than the
chlorinated monomers and has LD value of
80-90 mg/kg body weight in rats and 27
mg/kg body weight in mice. It has also been
shown to be mutagenic after metabolic
activation with liver enzymes. In animals,
AN is metabolized to cyanide, which is
converted to thiocyanate and excreted in the
urine. There is also some evidence of
carcinogenicity in animals and possibly
humans too.
As per US-FDA, styrene-maleic
anhydride copolymers shall not contain
residual styrene monomer more than 0.1
weight percent. In nitrile rubber modified
acrylonitrile-methyl acrylate copolymers,
the residual acrylonitrile monomer content
is not more than 11 parts per million.
Chapter 3
Styrene
The LD value of styrene for rats is 5 g/kg
body weight. It is metabolized to styrene
and its oxide, which is a potent mutagen in
a number of test systems. Both styrene and
its oxide have been prone to produce chro-
mosomal aberrations under certain condi-
tions. Toxic effects of styrene in humans
have been reviewed by IARC. The most fre-
quently observed changes were of neuro-
logical and psychological nature.
Limit : The total residual monomers, when
present, shall not exceed 0.2 percent by mass
of the polymer, as per Indian Standard. As
per US-FDA styrene-maleic anhydride
copolymers shall not contain residual
styrene monomer more than 0.3 weight
percent. Polystyrene basic polymers shall
contain not more than 1 weight percent of
total residual styrene monomer.
Colourants in Plastics
Plastics are increasingly coloured to
enhance the attractiveness of packaging, to
protect the contents from the adverse effects
of light or to differentiate between products.
Depending on the type of packaging, the
contents and the storage conditions, it is
possible that components in the packaging,
including colourants, could migrate to the
food. It must therefore be ensured that the
packaging components, including colou-
rants, do not pose a health hazard to the
consumer. This is also the aim of the relevant
directives, laws and regulations.
The colouration of plastics, which come
into contact with food, is an important
application for the colourants industry. The
following basic criteria are decisive for the
safe use of colourants for the colouration of
food contact articles and packaging:
PLASTICS IN FOOD PACKAGING
FOOD GRADE QUALITY OF PLASTICS AND REGULATIONS
1. Purity criteria of the colourants,
2. Its fastness to migration,
3. The tested toxicological properties.
The colourant manufacturers guarantee
that the colourants have been toxicologically
tested and that the purity criteria are met.
The manufacturers of the food contact article
or packaging material are responsible for the
migration testing.
Consumer safety is a joint responsibility
of manufacturers, processors and authorities.
For the consumer, the safe use of coloured
plastic food contact articles is already
provided for by the current regulations in
combination with a responsible approach
by the pigment manufacturers and
processors. Nevertheless, new knowledge
must always be taken into account.
Basically, the problem of colour migration
is found in vegetable oils, when they are
packed into coloured polythene containers.
CFTRI has developed simple methods to
detect the colour migration qualitatively from
plastics, within few hours, using decolouri-
sed coconut oil. However, the quantitative
estimation can also be done using spectro-
scopic analysis.
As per US-FDA 178.3297 Colourants and
Polymers, the substances may be safely used
as colourants in the manufacture of articles
or components of articles intended for use in
producing, manufacturing, processing,
preparing, treating, packaging, transporting
or holding food. The term colourant means a
dye pigment, or other substance that is used
to impart colour to or to alter the colour of a
food-contact material, but that does not
migrate to food in amounts that will
contribute to that food any colour apparent
to the naked eye.
PLASTICS IN FOOD PACKAGING
69
As per Indian standards, colour migrated
to simulant or decolourised coconut oil or
food packed shall not be apparent to naked
eye. If the colour migrated is clearly visible,
such materials are not suitable for food
contact applications, even though the
extractive value is within the limit as in IS:
9833-1981.
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72 Chapter 3

PLASTICS IN FOOD PACKAGING